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NCT06399328Completed

Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy

Cardiovascular Risk Stratification on the Basis of Surface Enhanced Raman Spectroscopy. Assessment of Technology for Early Subclinical Detection of Coronary Heart Disease Based on Serum Metabolic Shifts .

Source: ClinicalTrials.gov · Last updated 16 Oct 2026

Brief summary (registry, in English)

In the modern population, mortality and disability from cardiovascular diseases is predominant and is realized as a major medical and social problem. The study of mechanisms of development of age-related diseases, such as coronary heart disease (CHD), has demonstrated multiple qualitative and quantitative changes of metabolites in biological fluids of the body - blood, in the vascular wall, as well as in the tissues of vital organs. In routine clinical practice only about a dozen metabolic parameters are determined by standard laboratory methods. The proposed approach belongs to a new scientific direction , wich development is aimed at individualization of approaches to risk stratification of cardiovascular diseases and their complications. The data obtained in this project will allow to create a base of medical knowledge about spectral characteristics of blood serum, which most fully reflect the metabolic profile associated with atherosclerosis of coronary arteries. Researchers offer so-called multiplex diagnostics when multiple parameters of a biological object obtained by serum biochemical analysis and optical scattering analysis are used. Recognition of this big data is possible only by methods of mathematical analysis, which can take into account the degree of deviations, their directionality in each point of the spectral characteristic. Until recently, the standard setup for Raman light scattering studies had significant dimensions. The high cost of such installations made it difficult to widely use the method of optical spectroscopy for rapid analysis of medical objects. In recent years, the situation on the market of scientific instrumentation has changed radically, which allowed to significantly reduce and cheapen all components of Raman installations.This simplification and cheapening allows to bring optical research in medicine (optical biopsy) to a new level of use, directly into clinical laboratories. Novelty: This area of research belongs to high-tech and is very little represented in Europe. The prospect of using Surface Enhanced Raman spectroscopy (SERS) to determine subclinical lesions of coronary arteries and for risk stratification of diseases associated with atherosclerosis is quite unique and wasn't explored yet.

Status (registry)
Completed
Study type
Observational
Enrollment
220 (actual)
First submitted
18 Apr 2024
Start date
15 Sept 2023
Primary completion date
15 Sept 2025
Lead sponsor
Samara State Medical University
NCT number
NCT06399328

What you commit to

  • Study type: Observational
  • Participants enrolled: 220
  • From 15 Sept 2023 to the primary completion date, 15 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • tachycardia, irregular heart rhythm
  • known at the time of inclusion: Acute Coronary Syndrom, myocardial infarction,any form of verified CHD, operated for coronary atherosclerosis (PCI) peripheral arteries (carotid, renal, leg),stroke of any kind.
  • established diagnosis or clinical signs of chronic heart failure.
  • Type 1 diabetes mellitus (DM) or type 2 DM requiring insulin therapy
  • oncologic diseases, cirrhosis ,
  • dementia disorders,

Lab values

  • familial hypercholesterolemia (total cholesterol 7.5 mmol/L or more),
  • Creatinine 135 µmol/L or higher;
  • anemia Hemoglobin below 110g/l,

Other

  • obesity : body mass index (BMI) 35kg/m2 and above,
  • absence of informed consent.

Who the study is looking for

  • without cardiac pain
  • with atypical angina pectoris.
  • with typical angina pectoris .
  • possibly with asymptomatic atherosclerosis of carotid and other peripheral arteries not subject to surgical treatment (degree of stenosis not more than 50%) Possible combination with known type 2 diabetes mellitus not requiring insulin therapy, with hypertension stages 1-2.

Age in the registry: 30 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Regional Samara clinical hospital na V.D.Seredavin
Coordinator of this site? Confirm its status
SamaraRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.